Regulatory Manager (Permanent) – Medical Devices
Leicester (Hybrid) – Office-based culture with flexibility (approx. two days from home)
Applicants must have the right to work; sponsorship / future sponsorship cannot be supported.
This is an opportunity to step into a visible, commercially connected Regulatory role where you’ll shape market expansion for a leading UK manufacturer of Class IIb medical devices .
You’ll join a company with a diverse portfolio of consumer medical products sold through major high-street retailers and international partners. The business is privately owned, well-resourced, and operates with the spirit of an SME.
Due to steady growth, they are creating a new position to take the lead on global product registrations and drive market access across Asia, Africa, and other Rest-of-World regions .
You’ll also support ongoing MDR transition work alongside an experienced Senior Regulatory Manager.
The Opportunity
Visibility and Ownership:
Take responsibility for defining and executing global regulatory submissions while working closely with senior leadership.
Strategic Input:
Work with the commercial team to decide the most effective route to market — whether to register products via local distributors or retain legal manufacturer responsibility directly.
Market Expansion:
Lead regulatory submissions and product registrations worldwide, ensuring compliant and timely approvals across Rest-of-World territories.
Collaboration:
Partner with quality, manufacturing, and commercial teams to maintain compliance and enable new launches.
Career Growth:
Join at a time of expansion, with scope to progress towards the Head of Compliance role in the medium term.
Culture and Flexibility:
Enjoy an open, down-to-earth working environment with genuine flexibility.
How You’ll Make an Impact
• Lead regulatory submissions and product registrations across Asia, Africa, and other Rest-of-World markets.
• Advise on market entry strategy, helping assess regulatory complexity, cost, and timelines.
• Provide regulatory input for new product acquisitions, determining legal manufacturer and distributor responsibilities.
• Manage and support two Regulatory Associates.
• Contribute to MDR transition work where required.
• Collaborate across functions to ensure continued compliance and readiness for new product launches.
Who Will Thrive Here
• Experienced in medical device regulatory affairs, with multi-country registration experience .
• Commercially minded with the ability to balance compliance requirements with business goals.
• Skilled at building relationships and influencing cross-functional teams.
• Enjoys working in smaller, collaborative settings where responsibilities are broad and shared.
• Holds a scientific or technical degree (chemistry or related discipline preferred).
• Experience with sterile products or cosmetics is a plus, but medical devices expertise is key.
Who You’ll Be Joining
You’ll be part of a well-established UK manufacturer known for quality and innovation in medical devices and consumer health products.
With around 100 employees across two sites, the company combines the stability of a larger organisation with the agility and informality of a smaller team .
They’re strengthening their compliance frameworks and expanding into new international markets.
Collaboration, flexibility, and mutual support are at the heart of how they work.
Why This Role Stands Out
• Hybrid working – typically three days in the Leicester office.
• Supportive, people-focused culture where everyone contributes.
• Real career growth potential within a respected UK medical device company.
Apply today or contact Josh@indoprofessionals.co.uk